The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 30
- 主要终点
- Quality of life (EORTC-QLQ-30) summary score
研究概览
简要总结
The survival of patients with incurable gastroesophageal cancer can extend over a year with anticancer therapy. However, the number of patients with deteriorating quality of life in this patient group steadily decreases over time during the treatment. Potentially reversible causes related to deterioration of quality of life are diminished muscle mass, physical capacity and nutritional status. Therefore, interventions that can target these in order to maintain or improve quality of life are urgently needed.
However, it is yet unknown whether improvement of physical capacity and nutritional status improves quality of life in patients with incurable gastroesophageal adenocarcinoma after failure of first-line treatment. Since these patients are in a precarious situation, the benefits and harms of a combined exercise and nutritional intervention should be carefully evaluated.Therefore this study investigates the effect of a combined exercise and nutrition intervention compared to usual care on quality of life in incurable GAC patients after progression upon first-line treatment.
A total of 196 patients with metastasized gastroesophageal cancer will be recruited and randomly allocated 1:1 to standard care or standard care plus a combined exercise and nutritional intervention.
详细描述
Randomization will be stratified based on: duration of first line therapy (shorter or longer than 6 months), WHO performance status (0, 1 versus 2), (intended) start of second-line (or further) systemic therapy for progressive disease (yes versus no) and time since failure of first line therapy (shorter or longer than 3 months ago). Due to the nature of the intervention, it is not possible to blind the patients, the local study nurses, or the investigators to the treatment assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incurable adenocarcinoma of the esophagus or stomach.
- •Progressive disease after first-line palliative systemic treatment OR within 6 months after completion of curative treatment (i.e. within six months after neoadjuvant chemoradiation, adjuvant nivolumab, or definitive chemoradiation for esophageal adenocarcinoma or within six months after adjuvant 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) for gastric/esophageal cancer or neoadjuvant FLOT if no adjuvant FLOT was given, or after progression during participation in the LyRICX study). Patients on capecitabine monotherapy who are eligible for oxaliplatin reintroduction can be included, too. Inclusion can take place regardless of the plan or the actual initiation of multi-line systemic treatment. (i.e. patients that have already started with second/third/etc. line therapy are eligible for inclusion too)
- •Able and willing to perform the exercise and nutritional program and wear the activity tracker.
- •Able and willing to fill out the POCOP/RADICES questionnaires.
- •Life expectancy > 12 weeks.
- •Age ≥ 18 years.
排除标准
- •Unstable bone metastases inducing skeletal fragility as determined by the treating clinician.
- •Untreated symptomatic known brain metastasis.
- •Serious active infection.
- •Too physically active (i.e. >210 minutes/week of moderate-to-vigorous intentional exercise) or engaging in intense exercise training comparable to the RADICES exercise program.
- •Severe neurologic or cardiac impairment according to the American College of Sports Medicine criteria.
- •Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise.
- •Uncontrolled severe pain.
- •Any other contraindications for exercise as determined by the treating physician.
- •Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician.
- •Pregnancy.
结局指标
主要结局
Quality of life (EORTC-QLQ-30) summary score
时间窗: Baseline, 6 weeks and every 12 weeks up to one year after intervention
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item. The summary score encompasses the last question of this questionnaire. Scale: 1-7 Higher score means better quality of life. Analyzed will be the difference in quality of life between the intervention group and the control group at 12 weeks, taking into account the baseline values, and measured with the Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
次要结局
- Skeletal muscle index(Baseline, 12 weeks.)
- Body composition: Fat mass(Baseline, 12 weeks)
- Aerobic capacity: MSEC(Baseline, 12 weeks)
- Body composition: Muscle mass(Baseline, 12 weeks)
- Medical effects: duration of systemic therapy(Baseline up to one year after intervention)
- Physical activity(Baseline, 12 weeks)
- Medical effects: dose reductions(Baseline up to one year after intervention)
- Quality of life (EORTC-QLQ-30) total score(Baseline, 6 weeks and every 12 weeks up to one year after intervention)
- Muscle strength: leg press maximal muscle strength(Baseline, 12 weeks)
- Medical effects: Treatment toxicity(Baseline up to one year after intervention)
- Muscle strength: Hand grip strength(Baseline, 12 weeks)
- Body composition: Weight(Baseline, 12 weeks)
- Self-reported screening of sarcopenia(Baseline,12 weeks)
- Medical effects: dose delays(Baseline up to one year after intervention)
- Progression-free survival(Baseline up to one year after intervention)
- Self-reported screening of malnutrition(Baseline and every 12 weeks up to one year after intervention)
- WHO performance status(Baseline and during the intervention, until the end of the intervention (12 weeks).)
- Medical effects: percentage of patients starting second-line treatment(Baseline up to one year after intervention)
- Patient reported physical activity(Baseline and every 12 weeks up to one year after intervention)
- Health-related quality of life: physical functioning(Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).)
- Health-related quality of life: role functioning(Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).)
- Overall survival(Baseline up to 1 year after intervention.)
- Health-related quality of life: fatigue(Baseline and every 2 weeks during the intervention, until the end of the intervention (12 weeks).)
研究者
Hanneke W. M. van Laarhoven
Head of Medical Oncology of Amsterdam AMC, Principal Investigator, Prof. dr. H.W.M. van Laarhoven
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)